USP General Chapter <795> - US Pharmacopeia (USP)
USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter …
Our speaker Brenda Jensen declares that she has a current affiliation or financial arrangement with an ineligible company as an owner of Compounding Consultants, LLC. Brian Serumaga is …
The revised <797> includes several factors to be considered when establishing BUDs for Category 2 CSPs, including aseptic processing and sterilization method, starting components, …
〈795〉 PHARMACEUTICAL • Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), COMPOUNDING—NONSTERILE teaching, or …
In the new version of 797, rinses for wounds are not mentioned as needing to be sterile, but they were specifically called out as a sterile item in the old version.
– Sterility assurance in 〈797〉 – Operational implications – Balancing the need for patient access to cost-effective compounded preparations with rigorous quality
Proposed 2021 Revisions to USP General Chapters to 795 and 797
2021年9月1日 · Stability Study Reference Document for the 2021 Proposed Revisions to <795> and <797> USP General Chapter <795> Informational Documents. USP General Chapter …
2020年4月24日 · On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile compounding and General Chapter <797> for sterile compounding, as well as a …
General Chapters: <797> PHARMACEUTICAL COMPOUNDING …
Sterile compounding differs from nonsterile compounding (see Pharmaceutical Compounding Nonsterile Preparations 795 and Good Compounding Practices 1075) primarily by requiring a …
USP Compounding General Chapters <795> and <797> Final …
2022年11月16日 · The revisions to <795> and <797> reflect advancements in science and practice to help ensure quality compounded preparations, promote public health, and protect …